20 results
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18ms
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Sources: EU EUDAMED, US FDA
IMPROVED DENTAL OPERATING LIGHT
FDA 510(k)
FDA Class 1
·Dental
Wallach EndoBlock Needle
FDA UDI
Coopersurgical, Inc.·20888937011207·Endocervical Block Needle with Luer Lock Hub
SOLAR SHIELD
FDA UDI
FGX INTERNATIONAL INC.·00733732239287·
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200171·Mand. 1. Molar band W-Fit left 17
SOLAR SHIELD
FDA UDI
FGX INTERNATIONAL INC.·00887661346131·
SOLAR SHIELD
FDA UDI
FGX INTERNATIONAL INC.·00846150005607·
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837014841·
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110928·STERILIZING CASE SINGLE VR
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200170051·Mand. 1. Molar band W-Fit left 17
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200170501·Mand. 1. Molar band W-Fit left 17
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200170101·Mand. 1. Molar band W-Fit left 17
Arthrex®
FDA UDI
ARTHREX, INC.·00888867058125·UNIVERS TRIAL STEM, 7MM
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDX 1000 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
ARTICUL/EZE BALL 28 + 5 BR
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD·Product code JDI·December 3, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·January 17, 2013
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017